MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL, STANDARD T2 TIBIA Ø12X315 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18221231S
Medical Device Problem Codes	Material Fragmentation (1261); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: "the lower (distal) hole of the stryker tibial centromedullary nail was not adapted to the diameter required for the 4.2 drill bit.This led to great difficulty for the surgeon.Resistance was felt by the surgeon when inserting the drill and also when positioning the screw.In addition, when removing the drill bit, pieces of titanium were found on it.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device is implanted in patient.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that: "the lower (distal) hole of the stryker tibial centromedullary nail was not adapted to the diameter required for the 4.2 drill bit.This led to great difficulty for the surgeon.Resistance was felt by the surgeon when inserting the drill and also when positioning the screw.In addition, when removing the drill bit, pieces of titanium were found on it.".

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø12X315 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19040570
• Report Number: 0009610622-2024-00131
• Device Sequence Number: 7270880
• Product Code: HSB
• UDI-Device Identifier: 04546540198150
• UDI-Public: 04546540198150
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 18221231S
• Device Lot Number: K0D6158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown